HUDSON RCI HUD1059Recalls & reported problems
Medline Industries, Inc. · MASK NONREBREATHER ADULT · Class 1
All models of HUDSON RCI (30)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10197344042180), received between Aug 27, 2026 and Sep 30, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component2
- Loose or Intermittent Connection1
- Material Rupture1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950667 ↗MalfunctionSep 13, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50747545 ↗MalfunctionAug 27, 2026Loose or Intermittent Connection; Detachment of Device or Device Component
It was reported that the mask disconnects during use, preventing the patient from receiving oxygen. The issue that multiple anesthesia providers have voiced is that the tubing easily falls off of the mask connector.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50477876 ↗
Other MASK, OXYGEN, NON-REBREATHING devices
- HUDSON RCI HUD1060Medline Industries, Inc. · MASK, OXYGEN, NON-REBREATHING5 reports
- n/a 8130-7Salter Labs · MASK, OXYGEN, NON-REBREATHING2 reports
- HUDSON RCI HUD1936Medline Industries, Inc. · MASK, OXYGEN, NON-REBREATHING1 report
- n/a SO-298-0Salter Labs · MASK, OXYGEN, NON-REBREATHING1 report
- n/a SO-430-0Salter Labs · MASK, OXYGEN, NON-REBREATHING1 report
- n/a 8140-7Salter Labs · MASK, OXYGEN, NON-REBREATHING1 report
- AirLife™ 001203Vyaire Medical, Inc. · MASK, OXYGEN, NON-REBREATHING1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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